Label Changes for:
Vesicare (solifenacin succinate)
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2012
WARNINGS AND PRECAUTIONS
Central Nervous System Effects
- Vesicare is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including headache, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how VESIcare affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.